Manufacture

Manufacture Advanced Medicine

Kite, CAR Ts, and Access for Patients

04/25/2025 | Stephanie Vine | 9 min read

Depending on the country, only about two in 10 eligible patients, on average, receive CAR T-cell therapy. We sat down with Kite’s Cindy Perettie to talk about access to CAR Ts.

Manufacture Facilities

FUJIFILM Diosynth and Regeneron Sign 10-Year, $3 Billion Manufacturing Agreement

04/22/2025 | Stephanie Vine | 2 min read

FUJIFILM Diosynth to manufacture biologics for Regeneron at new facility in Holly Springs, North Carolina.

Manufacture Advanced Medicine

Advancing AAV Manufacturing Quality

04/22/2025 | Efrain Guzman | 3 min read

Overcoming the limitations of the triple plasmid transient transfection method for AAV manufacturing.

Manufacture Advanced Medicine

Cell Therapy: Getting GMP Right

04/16/2025 | Stephanie Vine | 2 min read

Open-access research paper outlines quality and regulatory considerations for cell therapy manufacturing programs.

Manufacture Advanced Medicine

Coming Soon: the Power List

04/11/2025 | Rob Coker | 2 min read

The 2025 Power List will be available soon!

Manufacture Contract Development Services

Partnerships To Be Precise

04/11/2025 | Elizabeth Hickman, Dave Miller | 3 min read

In the highly regulated precision medicine development sector, the agility and expertise of a CDMO can make or break a commercial drug candidate.

Manufacture Advanced Medicine

The Next Decade of Cell and Gene Therapies

04/02/2025 | 5 min read

Off-the-shelf allogeneic CAR-Ts, increased manufacturing productivity led by digital systems; we ask experts about the future of advanced medicine.

Manufacture Advanced Medicine

Building a Resilient CGT Workforce

03/26/2025 | Daniel Palmacci | 3 min read

With competition for skilled employees in cell and gene therapy manufacturing high, companies need to invest in training and mentorship.

Manufacture Quality & Compliance

Innovating Pharmaceutical Packaging

03/25/2025 | 3 min read

Michiel van den Berg sheds light on the challenges and opportunities facing the industry as it adapts to new materials and regulatory requirements

Manufacture Technology and Equipment

The Myths and Reality of Hot Melt Extrusion

03/20/2025 | Hibreniguss Terefe, Shahab Kashani Rahimi | 6 min read

How hot melt extrusion can enhance drug solubility and bioavailability, offering advantages over spray drying for oral dosage form development.

Manufacture Technology and Equipment

The Role of the Robot

03/17/2025 | 3 min read

From cybersecurity challenges and AI-driven decision-making, to making mundane tasks more skillful, robotics is reshaping pharmaceutical operations.

Manufacture Facilities

FDA Warning Letters: March 2025 Edition

03/13/2025 | Stephanie Vine | 3 min read

Indian CDMO denies manufacturing drug, contract testing lab pulled up for deficiencies, and lessons learned from Sanofi’s warning letter.

Manufacture Advanced Medicine

Partnership Cuts Cost of CAR T Manufacturing

03/13/2025 | 4 min read

Manufacturing bottlenecks remain a key hurdle in CAR-T therapy. Can automation and digital integration change that?